From AbbVie's upadacitinib to new gene therapies: Pharma's 2019 blockbuster launches, ranked

AbbVie
Even as AbbVie's bestselling Humira takes a hit due to biosimilar competition in Europe, the company's upadacitinib is the biggest blockbuster launch expected across pharma in 2019, according to Cortellis. (AbbVie)

Nary a pharma company would turn away a blockbuster launch, but thanks to patent cliffs and impending biosimilars, some drugmakers need them more than others. AbbVie, for one, with Humira aging fast—and it's about to get a couple this year, analysts say.

Alexion will have a chance to back up its top-selling Soliris, too, the number crunchers at Cortellis said this week. Novartis is set to disrupt the spinal muscular atrophy market—and make big pricing headlines—with its new blockbuster-to-be gene therapy. And AstraZeneca and Boehringer Ingelheim both have $1 billion-plus drug on tap, too.

The biopharma industry will see seven blockbuster launches this year, according to Clarivate's annual “Drugs to Watch” list for 2019. And good thing for AbbVie, its rheumatoid arthritis medication upadacitinib, a follow-up to the company’s bestselling Humira, is at the top of the list. Upadacitinib will likely score a U.S. approval in August and a European approval in October, the analysts figured, and by 2023, it'll pull in $2.2 billion.

But even so, that number would fall far short of megablockbuster RA drug Humira, which nearly generated $20 billion last year—and it'll face biosimilar competition that same year. Under agreements with a variety of biosim makers, Humira copycats are set to appear in the U.S. in 2023. They're already on the market in Europe.

RELATED: AbbVie inks Humira patent deal No. 7, delaying Pfizer's U.S. biosim launch until late 2023 

Behind upadacitinib in Cortellis’ ranking is Novartis’ Zolgensma, a drug that’ll be sure to generate headlines throughout its launch. That’s partly due to a price tag that's expected to be in the millions of dollars. Zolgensma is a gene therapy intended to cure spinal muscular atrophy. Currently, Biogen’s Spinraza leads the market and costs $750,000 before discounts for the first year, then $375,000 before discounts for subsequent years.  

Novartis expects a first-half 2019 launch in the U.S. and Japan, Cortellis said. The analytics firm predicts $449 million in sales this year, and $2.09 billion in 2023. Novartis has been an industry leader in its commitment to cell and gene therapies and won the first-ever CAR-T approval back in 2017 for Kymriah. 

RELATED: Novartis building out cell and gene therapy platform that'll lead the pack, CEO promises 

AstraZeneca and FibroGen’s roxadustat claims the No. 3 ranking in Cortellis’ Drugs to Watch ranking, with expected 2023 sales of $1.97 billion. The drug treats anemia related to chronic kidney disease and has already won approval in China. A U.S. filing is expected in the third quarter, Cortellis said. The analysts expect the China launch to come in the second half of 2019.

Right on roxadustat’s heels in 2023 sales projections is Alexion’s paroxysmal nocturnal hemoglobinuria drug Ultomiris, a follow-up to the company’s successful Soliris. Ultomris won FDA approval late last year and is dosed every eight weeks versus every two weeks for Soliris. Analysts predict the drug will generate $1.93 billion in 2023 sales. Alexion launched the drug in January.  

Alexion is hoping to switch patients from Soliris with a slight discount. The new drug carries a 10% discount to Soliris, Leerink analyst Geoff Porges wrote in a note, which would put its annual cost at around $450,000.

Boehringer Ingelheim and AbbVie’s Skyrizi captures the No. 5 position in Cortellis’ Drugs to Watch ranking. The psoriasis drug carries 2023 sales expectations of $1.74 billion. Analysts expect approvals in the U.S., Europe and Japan in the first half of this year. Aside from psoriasis, the companies are testing the drug in psoriatic arthritis, asthma, Crohn's disease and ulcerative colitis, Cortellis pointed out. 

RELATED: FDA gifts Alexion quick OK for Soliris follow-up Ultomiris 

Aimmune’s peanut allergy drug AR-101 and bluebird bio’s beta thalassemia gene therapy LentiGlobin round out the seven blockbuster launches expected in 2019. The drugs carry 2023 sales expectations of $1.17 and $1.12 billion, respectively. Cortellis expects an FDA approval in November for AR-101. The analysts predict a European approval for LentiGlobin in November and a U.S. approval to follow in 2021. 

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